# K160568: Precision Spine Interspinous Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Precision Spine, Inc.
- Decided: May 4, 2016 after 65 days
- Product code: PEK (Spinous Process Plate)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K033826 (2004). 49 ancestors in all.
No later device cites it as a predicate yet.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151863: Precision Spine Interspinous Plate System, Precision Spine, Inc. (2015) Summary page 5.
- K142378: Interspinous Plate System, Precision Spine, Inc. (2014) Summary page 5.
- K093438: Paradigm Interspinous Fusion Plate, Paradigm Spine, LLC (2010) Summary page 5.
- K112595: Coflex-F, Paradigm Spine, LLC (2012) Summary page 5.

## Indications for use
The Interspinous Plate System is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1) of skeletally mature patients. It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (i.e. fracture or dislocation), spondylolisthesis, and/or tumor. It is not intended for stand-alone use.

Source page: https://510kreport.com/device/K160568
Methodology: https://510kreport.com/methodology